Psoriasis VulgarisPhase 2NCT01600222
Effect of LEO 90100 on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis VulgarisExtensive Psoriasis Vulgaris
A Phase 2 study testing LEO 90100 in people with Psoriasis Vulgaris, run by LEO Pharma at 10 sites in Canada.
Trial summary
A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of LEO 90100 used once daily in subjects with extensive psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 90100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 10 sitesCanada
- Study dates
- May 2012to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained prior to any trial related activities (including any washout period)
- Age 18 years or above
- Either sex
- Any race or ethnicity
- Any skin type
- Attending a hospital out-patient clinic or the private practice of a dermatologist for treatment of psoriasis vulgaris
Show all 16Show fewer
- At SV2 and Day 0 (Visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs and the scalp which is;
- amenable to topical treatment with a maximum of 120g of study medication per week
- of an extent of between 15 and 30% of the body surface area (BSA) excluding psoriatic lesions of the face, genitals and skin folds
- including at least 30% scalp involvement
- of at least a moderate disease severity according to the investigators global assessment (IGA)
- At SV2, a normal HPA axis function including a serum cortisol concentration above 5 mcg/dl before ACTH-challenge and above 18 mcg/dl 30 minutes after ACTH-challenge
- At SV2, an albumin-corrected serum calcium below the upper reference range limit
- At SV2, females of child-bearing potential must have a negative urine pregnancy result
- Females of child-bearing potential must agree to use a highly effective method of contraception during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year)
- Able to communicate with the investigator and understand and comply with the requirements of the study
Who cannot join
- A history of allergic asthma, serious allergy or serious allergic skin rash
- Known or suspected hypersensitivity to component(s) of LEO 90100 or CORTROSYN (including cosyntropin/tetracosactide)
- Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2
- Systemic treatment with biological therapies (whether marketed or not marketed), with a possible effect on psoriasis vulgaris within the following time period prior to Day 0 (Visit 1);
- etanercept - within 4 weeks
- adalimumab, alefacept, infliximab - within 8 weeks
Show all 38Show fewer
- ustekinumab - within 16 weeks
- other products - within 4 weeks/5 half-lives (whichever is longer)
- Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to Day 0 (Visit 1)
- Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to Day 0 (Visit 1)
- PUVA therapy within 4 weeks prior to Day 0 (Visit 1)
- UVB therapy within 2 weeks prior to day 0 (Visit 1).
- Topical treatment with corticosteroids or vitamin D analogues on any body location within 2 weeks prior to SV2
- Any topical treatment of psoriasis vulgaris on the trunk, limbs or scalp (except for emollients and non-medicated shampoos) within 2 weeks prior to Day 0 (Visit 1)
- Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g., betablockers, antimalarials, lithium, ACE inhibitors) during the study
- Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to SV2. Note: Stable doses of oral vitamin D supplementation ≤400 IU/day is permitted provided there are no dose adjustments during the study period
- Planned initiation of, or changes to concomitant medication that could affect calcium metabolism (e.g. antacids, thiazide and/or loop diuretics, antiepileptics) during the study
- Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sunlamps etc.) during the study
- Oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2
- Cytochrome P450 3A4 (CYP 3A4) inducers (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2
- Systemic cytochrome P450 3A4 (CYP 3A4) inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2
- Topical cytochrome P450 3A4 (CYP 3A4) inhibitors (e.g., ketoconazole) within 2 weeks prior to SV2
- Non-nocturnal sleep patterns (e.g. night shift workers)
- Any of the following conditions, whether known or suspected:
- depression and endocrine disorders (e.g. Cushing's disease, Addison's disease, diabetes mellitus) known to affect cortisol levels or HPA axis integrity
- disorders of calcium metabolism associated with hypercalcaemia
- cardiac disorders associated with abnormal QT intervals or rhythm disturbances including clinically significant bradycardia or tachycardia
- severe renal insufficiency
- severe hepatic disorders
- Any clinically significant abnormality following blood pressure/heart rate measurement or review of screening laboratory tests (blood and spot urine samples) collected at SV2
- Any clinically significant abnormality following physical examination at SV1
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- Any of the following conditions present on the study treatment areas (trunk, limbs and scalp): viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds
- Other inflammatory skin disorders (e.g. seborrhoeic dermatitis and contact dermatitis) that may confound the evaluation of psoriasis vulgaris
- Current participation in any other interventional clinical trial
- Previously enrolled in this trial
- Known or suspected of not being able to comply with the trial protocol (e.g., alcoholism, drug dependency or psychotic state)
- Females who are pregnant, wishing to become pregnant during the study or who are breast-feeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
Maritime Medical Research Center
Bathurst, New Brunswick, E2A 4Z9
Co-Medica
Courtice, Ontario, L1E 3C3
Mediprobe Research
London, Ontario, N5X 2P1
Centre de Dermatologie Maizerets
Québec, Quebec, G1J 1X7
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
PerCuro Clinical Research
Victoria, British Columbia, V8V 3P9
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
About this study
Official title: A Phase 2 Maximal Use Systemic Exposure (MUSE) Study Evaluating the Safety and Efficacy of LEO 90100 Used Once Daily in Subjects With Extensive Psoriasis Vulgaris
A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.
Read the detailed description
The purpose of the present study is to assess the systemic safety of LEO 90100. Although LEO 90100 contains the same active ingredients in the same concentration as DAIVOBET/DOVOBET/TACLONEX ointment, the degree of absorption of the active ingredients from the new formulation may differ. Systemic safety will be assessed through the effect of LEO 90100 on calcium metabolism and HPA axis function under maximum use conditions (i.e., in subjects with very extensive psoriasis on the trunk, limbs and scalp, using up to 120g per week of LEO 90100 for up to 4 weeks). Data from this study, together with the measurements of albumin-corrected serum calcium and the calcium:creatinine ratio in spot urine samples in the planned phase 2 and 3 studies in the development program for LEO 90100, are expected to provide adequate information with respect to the systemic safety of LEO 90100.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 90100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90100Drug
Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
| Study group | Role | What they receive |
|---|---|---|
| LEO 90100 | Experimental | Not described Receives: Drug: LEO 90100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)
HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.
Measured: Day 28
Change in Albumin-corrected Serum Calcium From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.
Measured: Baseline and Day 28
Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.
Measured: Baseline and Day 28
Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.
Measured: Baseline and Day 28
Secondary outcomes (16)
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28
Serum cortisol concentrations at 30 and 60 minutes after injection were measured in order to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration is ≤18mcg/dl at 30 minutes after the injection.
Measured: Day 28
Number of Participants With an Adverse Drug Reaction (ADR)
Adverse drug reactions (ADRs) were defined as adverse events for which the investigator has not described the causal relationship to investigational medication as "not related".
Measured: Baseline to Day 28
Change in Serum Phosphate From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum phosphate from Baseline to Day 28.
Measured: Baseline and Day 28
Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary phosphate excretion from Baseline to Day 28.
Measured: Baseline and Day 28
Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary phosphate:creatinine ratio from Baseline to Day 28.
Measured: Baseline and Day 28
Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum ALP from Baseline to Day 28.
Measured: Baseline and Day 28
Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in plasma PTH from Baseline to Day 28.
Measured: Baseline and Day 28
Change in Blood Pressure From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (blood pressure).
Measured: Baseline and Day 28
Change in Heart Rate From Baseline to Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (heart rate).
Measured: Baseline and Day 28
Number of Subjects Who Discontinued From the Study
Number of subjects who discontinued from the study due to adverse events.
Measured: Baseline to Day 28
Pharmacokinetic Evaluation Cmax
The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
- AUC0-t
- AUC0-∞
- Cmax
- Tmax
- T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Cmax are derived from that 1 subject.
Measured: 4 weeks / 28 days
Pharmacokinetic Evaluation AUClast
The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
- AUC0-t
- AUC0-∞
- Cmax
- Tmax
- T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol AUClast are derived from that 1 subject.
Measured: 4 weeks / 28 days
Pharmacokinetic Evaluation AUCinf
The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
- AUC0-t
- AUC0-∞
- Cmax
- Tmax
- T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
Measured: 4 weeks / 28 days
Pharmacokinetic Evaluation Tmax
The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
- AUC0-t
- AUC0-∞
- Cmax
- Tmax
- T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Tmax are derived from that 1 subject.
Measured: 4 weeks / 28 days
Pharmacokinetic Evaluation T1/2
The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:
- AUC0-t
- AUC0-∞
- Cmax
- Tmax
- T½
If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.
Measured: 4 weeks / 28 days
Efficacy Evaluation
The percentage of subjects who achieved 'controlled disease' (i.e., Clear or Almost clear) according to the Investigator's Global Assessment (IGA) of disease severity on the trunk, limbs and scalp at Days 28 (Visit 3) and End of treatment (EoT) were presented.
Measured: 4 weeks I 28 days and End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicki Taraska, Principal investigator, Winnipeg Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600222
- Sponsor's protocol ID
- LEO 90100-30
- Status last verified
- Jul 2016
- First submitted
- 8 May 2012
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Taraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. Fixed combination aerosol foam calcipotriene (Cal) 0.005% plus betamethasone 0.064% (as dipropionate; BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Semin Cutan Med Surg. 2015;34 S1:PA-29.
Taraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Semin Cutan Med Surg 2014;33:abst PA-13.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Maximal Use Systemic Exposure (MUSE) Study Evaluating the Safety and Efficacy of LEO 90100 Used Once Daily in Subjects With Extensive Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01600222
- Acronym / sponsor ID
- LEO 90100-30
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 16 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.
Detailed description
The purpose of the present study is to assess the systemic safety of LEO 90100. Although LEO 90100 contains the same active ingredients in the same concentration as DAIVOBET/DOVOBET/TACLONEX ointment, the degree of absorption of the active ingredients from the new formulation may differ. Systemic safety will be assessed through the effect of LEO 90100 on calcium metabolism and HPA axis function under maximum use conditions (i.e., in subjects with very extensive psoriasis on the trunk, limbs and scalp, using up to 120g per week of LEO 90100 for up to 4 weeks). Data from this study, together with the measurements of albumin-corrected serum calcium and the calcium:creatinine ratio in spot urine samples in the planned phase 2 and 3 studies in the development program for LEO 90100, are expected to provide adequate information with respect to the systemic safety of LEO 90100.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEO 90100 | Experimental | Drug: LEO 90100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed and dated informed consent obtained prior to any trial related activities (including any washout period)
- Age 18 years or above
- Either sex
- Any race or ethnicity
- Any skin type
Key exclusion criteria (38 listed)
- A history of allergic asthma, serious allergy or serious allergic skin rash
- Known or suspected hypersensitivity to component(s) of LEO 90100 or CORTROSYN (including cosyntropin/tetracosactide)
- Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2
- Systemic treatment with biological therapies (whether marketed or not marketed), with a possible effect on psoriasis vulgaris within the following time period prior to Day 0 (Visit 1);
- Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to Day 0 (Visit 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 90100Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) | Drug | LEO 90100 |
Primary outcome
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)
Time frame: Day 28
HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.
Change in Albumin-corrected Serum Calcium From Baseline to Day 28
Time frame: Baseline and Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.
Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28
Time frame: Baseline and Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.
Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28
Time frame: Baseline and Day 28
The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.
16 secondary outcomes
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28
Time frame: Day 28
Number of Participants With an Adverse Drug Reaction (ADR)
Time frame: Baseline to Day 28
Change in Serum Phosphate From Baseline to Day 28
Time frame: Baseline and Day 28
Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28
Time frame: Baseline and Day 28
Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28
Time frame: Baseline and Day 28
Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28
Time frame: Baseline and Day 28
Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28
Time frame: Baseline and Day 28
Change in Blood Pressure From Baseline to Day 28
Time frame: Baseline and Day 28
Change in Heart Rate From Baseline to Day 28
Time frame: Baseline and Day 28
Number of Subjects Who Discontinued From the Study
Time frame: Baseline to Day 28
Pharmacokinetic Evaluation Cmax
Time frame: 4 weeks / 28 days
Pharmacokinetic Evaluation AUClast
Time frame: 4 weeks / 28 days
Pharmacokinetic Evaluation AUCinf
Time frame: 4 weeks / 28 days
Pharmacokinetic Evaluation Tmax
Time frame: 4 weeks / 28 days
Pharmacokinetic Evaluation T1/2
Time frame: 4 weeks / 28 days
Efficacy Evaluation
Time frame: 4 weeks I 28 days and End of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationTaraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. Fixed combination aerosol foam calcipotriene (Cal) 0.005% plus betamethasone 0.064% (as dipropionate; BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Semin Cutan Med Surg. 2015;34 S1:PA-29.
- Results publicationTaraska V, Tuppal R, Olesen M, Bang Pedersen C, Papp K. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Semin Cutan Med Surg 2014;33:abst PA-13.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicki Taraska principal investigator
Winnipeg Clinic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 90100 in people with Psoriasis Vulgaris, run by LEO Pharma at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge) (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600222, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.